510(k) K223294

SpineJack® Expansion Kit by Stryker Instruments — Product Code NDN

K223294 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the device "SpineJack® Expansion Kit". The FDA issued a decision of Substantially Equivalent on December 20, 2022. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Stryker Instruments has at least 10 other 510(k) clearances on record.